DISCOUNT DRUG MART

Product NDC
53943-556
Requested package NDC
53943-556-51
11-digit product format
539430556
Labeler code
53943
Product ID
53943-556_5115810d-2883-0ac3-e063-6394a90a562d
Type
HUMAN OTC DRUG
Nonproprietary name
EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL
Dosage form
LIQUID
Route
ORAL
Labeler
DISCOUNT DRUG MART
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-09-12
Substance
EUCALYPTOL; MENTHOL; METHYL SALICYLATE; THYMOL
Active strength
.92; .42; .6; .64 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

Additional Listing Data#

Finished product
Yes
Brand name base
DISCOUNT DRUG MART
Brand name suffix
Original Flavor Mouthwash
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EUCALYPTOL.92 mg/mL
MENTHOL.42 mg/mL
METHYL SALICYLATE.6 mg/mL
THYMOL.64 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RV6J6604TKInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup
3J50XA376EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043619Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
73e1b1f3-01dd-4609-9825-b598c6745c73Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53943-556-512022-09-12C16284748780-19d75b9cf-f7eb-f424-e053-dadaa90a57ce53943-556-51, Discount Drug Mart
53943-556-512020-01-31C16284748780-19d75b9cf-f7eb-f424-e053-dadaa90a57ce53943-556-51, Discount Drug Mart

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-556-51DISCOUNT DRUG MARTOriginal Flavor Mouthwash1500 mL in 1 BOTTLE, PLASTICLIQUID15005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EUCALYPTOLACTIVE INGREDIENTRV6J6604TKDISCOUNT DRUG MART ORIGINAL FLAVOR MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [DISCOUNT DRUG MART]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ADISCOUNT DRUG MART ORIGINAL FLAVOR MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [DISCOUNT DRUG MART]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YDISCOUNT DRUG MART ORIGINAL FLAVOR MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [DISCOUNT DRUG MART]1
THYMOLACTIVE INGREDIENT3J50XA376EDISCOUNT DRUG MART ORIGINAL FLAVOR MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [DISCOUNT DRUG MART]1
EUCALYPTOLACTIVE MOIETYRV6J6604TKDISCOUNT DRUG MART ORIGINAL FLAVOR MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [DISCOUNT DRUG MART]1
MENTHOLACTIVE MOIETYL7T10EIP3ADISCOUNT DRUG MART ORIGINAL FLAVOR MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [DISCOUNT DRUG MART]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZDISCOUNT DRUG MART ORIGINAL FLAVOR MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [DISCOUNT DRUG MART]1
THYMOLACTIVE MOIETY3J50XA376EDISCOUNT DRUG MART ORIGINAL FLAVOR MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [DISCOUNT DRUG MART]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDISCOUNT DRUG MART ORIGINAL FLAVOR MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [DISCOUNT DRUG MART]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMDISCOUNT DRUG MART ORIGINAL FLAVOR MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [DISCOUNT DRUG MART]1
CARAMELINACTIVE INGREDIENTT9D99G2B1RDISCOUNT DRUG MART ORIGINAL FLAVOR MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [DISCOUNT DRUG MART]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2DISCOUNT DRUG MART ORIGINAL FLAVOR MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [DISCOUNT DRUG MART]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDISCOUNT DRUG MART ORIGINAL FLAVOR MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [DISCOUNT DRUG MART]1
WATERINACTIVE INGREDIENT059QF0KO0RDISCOUNT DRUG MART ORIGINAL FLAVOR MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [DISCOUNT DRUG MART]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-556DISCOUNT DRUG MART ORIGINAL FLAVOR MOUTHWASH (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) LIQUID [DISCOUNT DRUG MART]4Current NDC, Legacy NDC, 1 package rows20241022_73e1b1f3-01dd-4609-9825-b598c6745c73.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DISCOUNT DRUG MART Original Flavor MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLDISCOUNT DRUG MART73e1b1f3-01dd-4609-9825-b598c6745c732026-05-05WarningsExact identifier
ndc (package): 53943-556-51
ndc (product): 53943-556
ndc11 (package): 53943055651

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN73e1b1f3-01dd-4609-9825-b598c6745c735
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD73e1b1f3-01dd-4609-9825-b598c6745c735
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY73e1b1f3-01dd-4609-9825-b598c6745c735

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53943-556-51539430556511500 mL in 1 BOTTLE, PLASTIC (53943-556-51) 1500 ml2022-09-120000-00-00NoNoCurrent